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Post by Thundersnow on Jan 5, 2024 23:36:52 GMT -5
Actual Study Start Date : September 29, 2021
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : April 2025
Ughhhhh!!!
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Post by longliner on Jan 5, 2024 23:39:11 GMT -5
Actual Study Start Date : September 29, 2021 Estimated Primary Completion Date : February 2024 Estimated Study Completion Date : April 2025
Ughhhhh!!!This fits with my thesis posted on the thread "non specific MNKD topics" don't despair, it may all work out fine. Or despair, it may not.  |
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Post by cjm18 on Jan 6, 2024 0:16:02 GMT -5
Actual Study Start Date : September 29, 2021 Estimated Primary Completion Date : February 2024 Estimated Study Completion Date : April 2025
Ughhhhh!!!Another reason to fire 37% of the sales force. What was it before? I thought earnings call said q4. |
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Post by sportsrancho on Jan 6, 2024 0:26:31 GMT -5
kevinmik 8:11PM
$MNKD Inhaled-1 Study Primary
Completion Date keeps getting push backed, likely due to the trial struggling to enroll patients. The study have been going on for over 2 years and is still not fully enrolled.
Here are the changes to the primiary completion dates:
Record Verification: August 2021
Primary Completion: April 2023
[Anticipated]
Record Verification: June 2023
Primary Completion: December 2023
[Anticipated]
Record Verification: September 2023
Primary Completion: February 2024
[Anticipated]
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Post by mytakeonit on Jan 6, 2024 1:23:17 GMT -5
I just checked on what is considered to be pediatric ... it is considered to be birth to 18 ... and maybe up to 21 years of age. So you could be in the military and be considered to be a baby. Ha!!!!
But, that's not mytakeonit
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Post by stella on Jan 6, 2024 8:03:28 GMT -5
Source/link on the extension of the peds trial?
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Post by sportsrancho on Jan 6, 2024 8:19:52 GMT -5
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Post by hellodolly on Jan 6, 2024 9:48:12 GMT -5
Clinicaltrials.gov last update was Jan 5, 2024. Primary completion date is 2/2024, next month with a year to do the analysis. Study completion date is 4/2025.
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Post by sayhey24 on Jan 6, 2024 10:32:32 GMT -5
Actual Study Start Date : September 29, 2021 Estimated Primary Completion Date : February 2024 Estimated Study Completion Date : April 2025
Ughhhhh!!!Another reason to fire 37% of the sales force. What was it before? I thought earnings call said q4. I believe what Mike said is we will have the numbers by Q4. I don't think that is changing. FDA approval should be 3Q2025 but should be the talk of ADA2025 along with any impacts the Cipla results can make to 2025 T2 SoC and label changes. He will have an update on this when he presents on Wednesday. |
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Post by agedhippie on Jan 6, 2024 11:11:14 GMT -5
Another reason to fire 37% of the sales force. What was it before? I thought earnings call said q4. I believe what Mike said is we will have the numbers by Q4. I don't think that is changing. FDA approval should be 3Q2025 but should be the talk of ADA2025 along with any impacts the Cipla results can make to 2025 T2 SoC and label changes. He will have an update on this when he presents on Wednesday. It's not changing, it already has changed! The old date: Primary Completion: December 2023, the new date: February 2024. The last endpoint will be six months after that so roughly Q3 before there are numbers. Then there is the QC phase which is another six months which is how we land at April 2025 for the final results from pediatrics. |
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Post by cjm18 on Jan 6, 2024 11:21:03 GMT -5
I believe what Mike said is we will have the numbers by Q4. I don't think that is changing. FDA approval should be 3Q2025 but should be the talk of ADA2025 along with any impacts the Cipla results can make to 2025 T2 SoC and label changes. He will have an update on this when he presents on Wednesday. It's not changing, it already has changed! The old date: Primary Completion: December 2023, the new date: February 2024. The last endpoint will be six months after that so roughly Q3 before there are numbers. Then there is the QC phase which is another six months which is how we land at April 2025 for the final results from pediatrics. FDA approval how long after that typically? |
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Post by sayhey24 on Jan 6, 2024 12:50:08 GMT -5
It's not changing, it already has changed! The old date: Primary Completion: December 2023, the new date: February 2024. The last endpoint will be six months after that so roughly Q3 before there are numbers. Then there is the QC phase which is another six months which is how we land at April 2025 for the final results from pediatrics. FDA approval how long after that typically? If they submit in May then add 6 months - November 2025? Lets see what Mike says on Wednesday. |
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Post by runner on Jan 6, 2024 20:15:53 GMT -5
He is not presenting on Wednesday, he is presenting on Thursday at 11:15 am Pacific time.
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Post by agedhippie on Jan 6, 2024 23:17:54 GMT -5
He is not presenting on Wednesday, he is presenting on Thursday at 11:15 am Pacific time. LQDA is presenting on Wednesday, also at 11:15 oddly enough. |
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Post by longliner on Jan 7, 2024 1:07:02 GMT -5
He is not presenting on Wednesday, he is presenting on Thursday at 11:15 am Pacific time. LQDA is presenting on Wednesday, also at 11:15 oddly enough. This would go well under "Other biopharma stocks" "Liquidia news".....oddly enough |
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